Republic of the Philippines

Department of Health
BUREAU OF FOOD AND DRUGS
Filinvest Corporate City
Alabang, Muntinlupa City

10 April 2003

BUREAU CIRCULAR
No. 05 s. 2003

RE : CLASSIFICATION OF HEMODIALYSIS PRODUCTS AS DRUGS

This Bureau Circular is issued to the public and our clients regarding the classification of hemodialysis
th
solutions. In line with this, we wish to quote p. 851 of Martindale The Extra Pharmacopoeia 30 Edition with regards
to dialysis solutions.

“Dialysis solutions are solutions of electrolytes formulated in concentration similar to those of extracellular
fluids. Dialysis solutions are used in the management of renal failure and poisoning; they allow the selective
removal of toxic substances, electrolytes and excessive body fluid from the blood. In hemodialysis, the exchange of
ions between the solution and the patient’s blood is made across a synthetic semipermeable-membrane. In
peritoneal dialysis, the exchange is made across the membrances of peritoneal cavity.”

The so-called exchange of ions in hemodialysis across a synthetic semipermeable membrane is a

mechanical and biochemical process. The hemodialysis solution supplements and replaces the electrolytes
required by the body while removing the accumulated toxic substances/fluids which ordinarily would have been
excreted by normally functioning kidneys. By the nature of this exchange and the systemic replaticement of ions,
hemodialysis products as stated int eh accompanying annex shall be classified as DRUGS.

All HEMODIALYSIS SOLUTIONS previously registered under Device shall be reclassified as DRUGS
accordingly.

This directive shall take effect immediately.

(Sgd) Prof. LETICIA-BARBARA B. GUTIERREZ, M.S.

Director
 retur
eval & ned
PRODUCT APPLICANT REG. MANUFACTURE DISTRIBUTO date to eval & date
RSN BRAND DS DF TYPE OLD RSN STAT 1 STAT 2
NAME COMPANY NO. R R decked pool decked 2
1 stora
ge
Potassium Chloride 2.75g,
Calcium Chloride 6.13g,
Acid Concentrate Sodium Chloride 174.35mg, Baxter Baxter DJM
02A- Biasol AC- DJM
for Hemodialysis Glacial Acetic Acid 8.85g, Solution Healthcare I 1 bot./5L Healthcare Phils. 11.13.0
0903 21 11.13.02
1K+ Magnesium Chloride 1.75g, Phils. Inc. Inc. 2
Dextrose Anhudrous 73.66g

Potassium Chloride 5.49g,

Calcium Chloride 7.15g,
Acid Concentrate Sodium Chloride 174.35mg, Baxter Baxter DJM
02A- Biasol AC- DJM
for Hemodialysis Glacial Acetic Acid 8.85g, Solution Healthcare I 1 bot./5L Healthcare Phils. 11.13.0
0904 23 11.13.02
2K+ Magnesium Chloride 1.75g, Phils. Inc. Inc. 2
Dextrose Anhudrous 73.66g

Retur
Each liter conc. Contains: ned
216.20g Sod. Chloride, 6.47g 02.0
Calcium Chloride, Dihydrate, 3.03
Euromed 1 CTC
02A- Hemodialysis Solucid AC 5.30g Potassium Chloride, Haemodialysis Euromed Labs., - CTC
Labs., Phils. I container/5 01.27.0
3142 Acid Concentrate 10 2.65g Magnesium chloride Solution Phils. Inc. class 01.27.03
Inc. L 3
Hexahydrate, 8.55g Glacial ified
Acetic Acid & 77.50g as
Dextrose Monohydrate devic
e
Retur
ned
Each liter conc. Contains:
02.0
216.20g Sod. Chloride, 6.47g
3.03
Calcium Chloride, Dihydrate, Euromed 1 CTC
02A- Hemodialysis Solucid AC Haemodialysis Euromed Labs., - CTC
5.30g Potassium Chloride, Labs., Phils. I container/5 01.27.0
3143 Acid Concentrate 07 Solution Phils. Inc. class 01.27.03
2.65g Magnesium chloride Inc. L 3
ified
Hexahydrate &8.55g Glacial
as
Acetic Acid
devic
e
Retur
Each liter conc. Contains: ned
216.20g Sod. Chloride, 6.47g 02.0
Calcium Chloride, Dihydrate, 3.03
Euromed 1 CTC
02A- Hemodialysis Solucid AC 5.30g Potassium Chloride, Haemodialysis Euromed Labs., - CTC
Labs., Phils. I container/5 01.27.0
3144 Acid Concentrate 09 2.65g Magnesium chloride Solution Phils. Inc. class 01.27.03
Inc. L 3
Hexahydrate, 8.55g Glacial ified
Acetic Acid & 77.50g as
Dextrose Monohydrate devic
e
 retur
eval & ned
PRODUCT APPLICANT REG. MANUFACTURE DISTRIBUTO date to eval & date
RSN BRAND DS DF TYPE OLD RSN STAT 1 STAT 2
NAME COMPANY NO. R R decked pool decked 2
1 stora
ge

Retur
ned
Each liter conc. Contains:
02.0
216.20g Sod. Chloride, 6.47g
3.03
Calcium Chloride, Dihydrate, Euromed 1 CTC
02A- Hemodialysis Solucid AC Haemodialysis Euromed Labs., - CTC
5.30g Potassium Chloride, Labs., Phils. I container/5 01.27.0
3145 Acid Concentrate 08 Solution Phils. Inc. class 01.27.03
3.60g Magnesium chloride Inc. L 3
ified
Hexahydrate, 8.55g Glacial
as
Acetic Acid
devic
e

HD-1A B.Braun JGP

02A- Hemodialysis-1A B.Braun Medical Zuellig JGP
Liquid Concentrate Medical I 1 x 5L 01.24.0
3081 Liquid Conc. Supplies Inc. Pharma Corp. 01.24.03
Conc. Supplies Inc. 3

Retur
ned
Sodium chloride 161.43g,
02.0
Potassium Chloride 5.500g
3.03
HD-3A Calcium Chloride 2H2O B.Braun CTC
02A- Hemodialysis-3A 1 canister x B.Braun Medical Zuellig - CTC
Liquid 6.77g, Magnesium Chloride Concentrate Medical I 01.27.0
3113 Liquid Conc. 10L Supplies Inc. Pharma Corp. class 01.27.03
Conc. 6H2O 3.74g. Glacial Acetic Supplies Inc. 3
ified
Acid 8.85g & Water for Inj. To
as
1000mL
devic
e
Sodium chloride 161.0g,
Potassium Chloride 5.500g
HD-4A B.Braun JGP
02A- Hemodialysis-4A Calcium Chloride 2H2O 7.0g, 1 canister x B.Braun Medical Zuellig JGP
Liquid Concentrate Medical I 01.24.0
3112 Liquid Conc. Magnesium Chloride 6H2O 5L Supplies Inc. Pharma Corp. 01.24.03
Conc. Supplies Inc. 3
3.7g. Glacial Acetic Acid 8.8g
& Water for Inj. To 1000mL
retur
ned
to
Acetate Baxter Baxter LSP stora
01A- Hemosol LSP
Concentrate for Solution Healthcare I 97F-486 Healthcare Phils. 09.25.0 ge
0699 DK-20 09.25.01
Hemodialysis Phils. Inc. Inc. 1 10.0
3.01
not
reap
 Liquid
Baxter DR- Baxter SOO CPR
01A- Bicarbonate SOO
Solution Healthcare X/I XY2716 99A-1440 Healthcare Phils. 10.11.0 10.22.0
2191 Concentrate for 10.11.01
Phils. Inc. 4 Inc. 1 1
Hemodialysis
Biasol AC-
22
Baxter Baxter JPM CPR
01A- Hemodialy JPM
Solution Healthcare X/I Healthcare Phils. 11.26.0 01.31.0
3163 sis 11.26.01
Phils. Inc. Inc. 1 2
Concentrat
e
Biasol AC-
20
Baxter Baxter JPM CPR
01A- Hemodialy JPM
Solution Healthcare X/I Healthcare Phils. 11.26.0 01.31.0
3164 sis 11.26.01
Phils. Inc. Inc. 1 2
Concentrat
e
Haemodialysis Euromed GM CPR Revalida
00A- DR- Euromed Labs., GM
Solution with Labs., Phils. CM 08.07.0 08.09.0 ted
1458 XY3380 Phils. Inc. 08.07.00
3.5% Dextrose Inc. 0 0 05.07.01

Haemodialysis
Solution without Euromed GM CPR Revalida
00A- DR- Euromed Labs., GM
Dextrose Labs., Phils. CM 08.07.0 08.09.0 ted
1543 XY3381 Phils. Inc. 08.07.00
(392.60/50L, Inc. 0 0 05.07.01
1570.00/20L)